Bipartisan Bill to strengthen testing of pediatric drugs launched in USA

29 March 2012

US Representative Mike Rogers (Republican, Michigan) this week introduced bipartisan legislation with Representatives Anna Eshoo (Democrat, California) and Ed Markey (Democrat, Massachusetts) that creates a permanent structure for strengthening testing of pediatric drugs and improving their safety.

“It is difficult to study and test prescription drugs for children, placing them at risk of being exposed to ineffective or harmful treatments,” said Rep Rogers, a senior member of the House Energy & Commerce Committee, nothing that “studying drugs in children is a risky, expensive, and scientifically challenging task.”

He explained that Congress recognized this problem and, in 1997, passed the Best Pharmaceuticals for Children Act (BPCA) to encourage companies to conduct more clinical trials of certain drugs in children. Congress also passed the Pediatric Research Equity Act (PREA) in 2003 to give the FDA authority to require pediatric testing as part of the new drug review and approval process. Rep Rogers’s legislation makes both successful programs permanent.

Making both programs permanent provides more certainty

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